| This page provides information on persons
accredited (as of the above date of revision) to review selected premarket notifications
[510(k)s] and the devices they may review. Information on this list will be updated
within 10 working days after the date reflected on the third party's accreditation
letter. Each classified device type on the list of devices eligible for Third Party
Review has one or more product codes associated with it. Devices eligible for review
by Third Parties are limited to the product codes shown on the list of eligible
devices. Please refer to the List of Devices for Third Party Review Under the FDA
Modernization Act (FDAMA) of 1997 to assure your device is eligible for the Accredited
Person Program. To-date, FDA has not withdrawn accreditation from any Accredited Person. |
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| TUV SUD AMERICA INC. |
|
1775 OLD HIGHWAY 8 NW
|
|
|
|
NEW BRIGHTON
MN
55112
1891
|
|
|
| Contact: | MS. DAWN M TIBODEAU, THIRD PARTY 510(K) PROJECT COORDINATOR |
| Phone: | 651 638 0288 ext |
| Fax: | 651 633 5286 |
| Email: |
| DTIBODEAU@TUVAM.COM |
| Internet: |
| |
|
|
|
| Panel | Section Number | Regulation Name / Device Name | Class |
| Anesthesiology |
| |
868.1040 |
POWERED ALGESIMETER |
II |
| |
868.1075 |
ARGON GAS ANALYZER |
II |
| |
868.1400 |
CARBON-DIOXIDE GAS ANALYZER |
II |
| |
868.1430 |
CARBON-MONOXIDE GAS ANALYZER |
II |
| |
868.1500 |
ENFLURANE GAS ANALYZER |
II |
| |
868.1620 |
HALOTHANE GAS ANALYZER |
II |
| |
868.1640 |
HELIUM GAS ANALYZER |
II |
| |
868.1670 |
NEON GAS ANALYZER |
II |
| |
868.1690 |
NITROGEN GAS ANALYZER |
II |
| |
868.1700 |
NITROUS-OXIDE GAS ANALYZER |
II |
| |
868.1720 |
OXYGEN GAS ANALYZER |
II |
| |
868.1730 |
OXYGEN-UPTAKE COMPUTER |
II |
| |
868.1750 |
PRESSURE PLETHYSMOGRAPH |
II |
| |
868.1760 |
VOLUME PLETHYSMOGRAPH |
II |
| |
868.1780 |
INSPIRATORY AIRWAY PRESSURE METER |
II |
| |
868.1800 |
RHINOANEMOMETER |
II |
| |
868.1840 |
DIAGNOSTIC SPIROMETER |
II |
| |
868.1850 |
MONITORING SPIROMETER |
II |
| |
868.1860 |
PEAK FLOW METER FOR SPIROMETRY |
II |
| |
868.1880 |
PULMONARY FUNCTION DATA CALCULATOR |
II |
| |
868.1890 |
PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR |
II |
| |
868.1900 |
DIAGNOSTIC PULMONARY FUNCTION INTERPRETATION CALCULATOR |
II |
| |
868.1920 |
ESOPYAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS |
II |
| |
868.2025 |
ULTRASONIC AIR EMBOLISM MONITOR |
II |
| |
868.2375 |
BREATHING FREQUENCY MONITOR |
II |
| |
868.2500 |
CUTANEOUS OXYGEN MONITOR |
II |
| |
868.2550 |
PNEUMOTACHOMETER |
II |
| |
868.2600 |
AIRWAY PRESSURE MONITOR |
II |
| |
868.2775 |
ELECTRICAL PERIPHERAL NERVE STIMULATOR |
II |
| |
868.5120 |
ANESTHESIA CONDUCTION CATHETER |
II |
| |
868.5130 |
ANESTHESIA CONDUCTION FILTER |
II |
| |
868.5140 |
ANESTHESIA CONDUCTION KIT |
II |
| |
868.5150 |
ANESTHESIA CONDUCTION NEEDLE |
II |
| |
868.5160 |
GAS MACHINE FOR ANESTHESIA |
II |
| |
868.5170 |
LARYNGO-TRACHEAL TOPICAL ANESTHESIA APPLICATOR |
II |
| |
868.5260 |
BREATHING CIRCUIT BACTERIAL FILTER |
II |
| |
868.5270 |
BREATHING SYSTEM HEATER |
II |
| |
868.5430 |
GAS-SCAVENGING APPARATUS |
II |
| |
868.5450 |
RESPIRATORY GAS HUMIDIFIER |
II |
| |
868.5630 |
NEBULIZER |
II |
| |
868.5655 |
PORTABLE LIQUID OXYGEN UNIT |
II |
| |
868.5665 |
POWERED PERCUSSOR |
II |
| |
868.5690 |
INCENTIVE SPIROMETER |
II |
| |
868.5710 |
ELECTRICALLY POWERED OXYGEN TENT |
II |
| |
868.5880 |
ANESTHETIC VAPORIZER |
II |
| |
868.5895 |
CONTINUOUS VENTILATOR |
II |
| |
868.6250 |
PORTABLE AIR COMPRESSOR |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Clinical Chemistry |
| |
862.1020 |
ACID PHOSPHATASE (TOTAL OR PROSTATIC) TEST SYSTEM |
II |
| |
862.1025 |
ADRENOCORTICOTROPIC HORMONE (ACTH) TEST SYSTEM |
II |
| |
862.1035 |
ALBUMIN TEST SYSTEM |
II |
| |
862.1045 |
ALDOSTERONE TEST SYSTEM |
II |
| |
862.1050 |
ALKALINE PHOSPHATASE OR ISOENZYMES TEST SYSTEM |
II |
| |
862.1065 |
AMMONIA TEST SYSTEM |
I |
| |
862.1070 |
AMYLASE TEST SYSTEM |
II |
| |
862.1085 |
ANGIOTENSIN I AND RENIN TEST SYSTEM |
II |
| |
862.1090 |
ANGIOTENSIN CONVERTING ENZYME TEST SYSTEM |
II |
| |
862.1100 |
ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM |
II |
| |
862.1110 |
BILIRUBIN (TOTAL AND DIRECT) TEST SYSTEM |
II |
| |
862.1113 |
BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM |
I |
| |
862.1118 |
BIOTINIDASE TEST SYSTEM |
II |
| |
862.1120 |
BLOOD GASES (PCO2, PO2) AND BLOOD PH TEST SYSTEM |
II |
| |
862.1140 |
CALCITONIN TEST SYSTEM |
II |
| |
862.1145 |
CALCIUM TEST SYSTEM |
II |
| |
862.1150 |
CALIBRATOR |
II |
| |
862.1155 |
HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM |
II |
| |
862.1160 |
BICARBONATE/CARBON DIOXIDE TEST SYSTEM |
II |
| |
862.1170 |
CHLORIDE TEST SYSTEM |
II |
| |
862.1177 |
CHOLYLGLYCINE TEST SYSTEM |
II |
| |
862.1187 |
CONJUGATED SULFOLITHOCHOLIC ACID (SLCG) TEST SYSTEM |
II |
| |
862.1205 |
CORTISOL (HYDROCORTISONE AND HYDROXYCORTICOSTERONE) TEST SYSTEM |
II |
| |
862.1215 |
CREATINE PHOSPHOKINASE/CREATINE KINASE OR ISOENZYMES TEST SYSTEM |
II |
| |
862.1225 |
CREATININE TEST SYSTEM |
II |
| |
862.1230 |
CYCLIC AMP TEST SYSTEM |
II |
| |
862.1295 |
FOLIC ACID TEST SYSTEM |
II |
| |
862.1310 |
GALACTOSE TEST SYSTEM |
I |
| |
862.1315 |
GALACTOSE-1-PHOSPHATE URIDYLTRANSFERASE TEST SYSTEM |
II |
| |
862.1340 |
URINARY GLUCOSE (NONQUANTITATIVE) TEST SYSTEM |
II |
| |
862.1345 |
GLUCOSE TEST SYSTEM |
II |
| |
862.1377 |
URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM |
II |
| |
862.1410 |
IRON (NON-HEME) TEST SYSTEM |
I |
| |
862.1415 |
IRON-BINDING CAPACITY TEST BINDING |
I |
| |
862.1445 |
LACTATE DEHYDROGENASE ISOENZYMES TEST SYSTEM |
II |
| |
862.1455 |
LECITHIN/SPHINGOMYELIN RATIO IN AMNIOTIC FLUD TEST SYSTEM |
II |
| |
862.1495 |
MAGNESIUM TEST SYSTEM |
I |
| |
862.1509 |
URINARY METHYLMALONIC ACID TEST SYSTEM |
II |
| |
862.1545 |
PARATHYROID HORMONE TEST SYSTEM |
II |
| |
862.1555 |
PHENYLALANINE TEST SYSTEM |
II |
| |
862.1580 |
PHOSPHORUS (INORGANIC) TEST SYSTEM |
I |
| |
862.1585 |
HUMAN PLACENTAL LACTOGEN TEST SYSTEM |
II |
| |
862.1600 |
POTASSIUM TEST SYSTEM |
II |
| |
862.1660 |
QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) |
I |
| |
862.1665 |
SODIUM TEST SYSTEM |
II |
| |
862.1675 |
BLOOD SPECIMEN COLLECTION DEVICE |
II |
| |
862.1680 |
TESTOSTERONE TEST SYSTEM |
I |
| |
862.1685 |
THYROXINE-BINDING GLOBULIN TEST SYSTEM |
II |
| |
862.1690 |
THYROID-STIMULATING HORMONE TEST SYSTEM |
II |
| |
862.1695 |
FREE THYROXINE TEST SYSTEM |
II |
| |
862.1700 |
TOTAL THYROXINE TEST SYSTEM |
II |
| |
862.1730 |
FREE TYROSINE TEST SYSTEM |
I |
| |
862.1770 |
UREA NITROGEN TEST SYSTEM |
II |
| |
862.1775 |
URIC ACID TEST SYSTEM |
I |
| |
862.1810 |
VITAMIN B12 TEST SYSTEMS |
II |
| |
862.1825 |
VITAMIN D TEST SYTEM |
II |
| |
862.2250 |
GAS LIQUID CHROMATOGRAPHY SYSTEM FOR CLINICAL USE |
I |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Cardiovascular |
| |
870.1100 |
BLOOD PRESSURE ALARM |
II |
| |
870.1110 |
BLOOD PRESSURE COMPUTER |
II |
| |
870.1120 |
BLOOD PRESSURE CUFF |
II |
| |
870.1130 |
NONINVASIVE BLOOD PRESSUE MEASUREMENT SYSTEM |
II |
| |
870.1140 |
VENOUS BLOOD PRESSURE MANOMETER |
II |
| |
870.1200 |
DIAGNOSTIC INTRAVASCULAR CATHETER |
II |
| |
870.1210 |
CONTINOUS FLUSH CATHETER |
II |
| |
870.1230 |
FIBEROPTIC OXIMETER CATHETER |
II |
| |
870.1240 |
FLOW-DIRECTED CATHETER |
II |
| |
870.1250 |
PERCUTANEOUS CATHETER |
II |
| |
870.1270 |
INTRACAVITARY PHONOCATHETER SYSTEM |
II |
| |
870.1280 |
STEERABLE CATHETER |
II |
| |
870.1290 |
STEERABLE CATHETER CONTROL SYSTEM |
II |
| |
870.1300 |
CATHETER CANNULA |
II |
| |
870.1310 |
VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION |
II |
| |
870.1330 |
CATHETER GUIDE WIRE |
II |
| |
870.1340 |
CATHETER INTRODUCER |
II |
| |
870.1370 |
CATHETER TIP OCCLUDER |
II |
| |
870.1380 |
CATHETER STYLET |
II |
| |
870.1390 |
TROCAR |
II |
| |
870.1425 |
PROGRAMMABLE DIAGNOSTIC COMPUTER |
II |
| |
870.1435 |
SINGLE-FUNCTION PREPROGRAMMED DIAGNOSTIC COMPUTER |
II |
| |
870.1450 |
DENSITOMETER |
II |
| |
870.1650 |
ANGIOGRAPHIC INJECTOR AND SYRINGE |
II |
| |
870.1660 |
INDICATOR INJECTOR |
II |
| |
870.1670 |
SYRINGE ACTUATOR FOR INJECTOR |
II |
| |
870.1800 |
WITHDRAWAL-INFUSION PUMP |
II |
| |
870.1875 |
STETHOSCOPE |
II |
| |
870.1915 |
THERMODILUTION PROBE |
II |
| |
870.2050 |
BIOPOTENTIAL AMPLIFIER AND SIGNAL CONDITIONER |
II |
| |
870.2060 |
TRANSDUCER SIGNAL AMPLIFIER AND SIGNAL CONDITIONER |
II |
| |
870.2100 |
CARDIOVASCULAR BLOOD FLOWMETER |
II |
| |
870.2120 |
EXTRAVASCULAR BLOOD FLOW PROBE |
II |
| |
870.2300 |
CARDIAC MONITOR (INCLUDING CARDIOTACHOMETER AND RATE ALARM) |
II |
| |
870.2310 |
APEX CARDIOGRAPH (VIBROCARDIOGRAPH) |
II |
| |
870.2320 |
BALLISTOCARDIOGRAPH |
II |
| |
870.2330 |
ECHOCARDIOGRAPH |
II |
| |
870.2340 |
ELECTROCARDIOGRAPH |
II |
| |
870.2350 |
ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR |
II |
| |
870.2360 |
ELECTROCARDIOGRAPH ELECTRODE |
II |
| |
870.2370 |
ELECTROCARDIOGRAPH SURFACE ELECTRODE TESTER |
II |
| |
870.2400 |
VECTORCARDIOGRAPH |
II |
| |
870.2450 |
MEDICAL CATHODE-RAY TUBE DISPLAY |
II |
| |
870.2675 |
OSCILLOMETER |
II |
| |
870.2750 |
IMPEDANCE PHLEBOGRAPH |
II |
| |
870.2770 |
IMPEDANCE PLETHYSMOGRAPH |
II |
| |
870.2780 |
HYDRAULIC, PNEUMATIC OR PHOTOELECTRIC PHETHYSMOGRAPH |
II |
| |
870.2800 |
MEDICAL MAGNETIC TAPE RECORDER |
II |
| |
870.2840 |
APEX CARDIOGRAPHIC TRANSDUCER |
II |
| |
870.2850 |
EXTRAVASCULAR BLOOD PRESSURE TRANSDUCER |
II |
| |
870.2860 |
HEART SOUND TRANSDUCER |
II |
| |
870.2870 |
CATHETER TIP PRESSURE TRANSDUCER |
II |
| |
870.2880 |
ULTRASONIC TRANSDUCER |
II |
| |
870.2890 |
VESSEL OCCLUSION TRANSDUCER |
II |
| |
870.2900 |
PATIENT TRANSDUCER AND ELECTRODE CABLE (INCLUDING CONNECTOR) |
II |
| |
870.2910 |
RADIOFREQUENCY PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER |
II |
| |
870.2920 |
TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER |
II |
| |
870.3630 |
PACEMAKER GENERATOR FUNCTION ANALYZER |
II |
| |
870.3640 |
INDIRECT PACEMAKER GENERATOR FUNCTION ANALYZER |
II |
| |
870.3720 |
PACEMAKER ELECTRODE FUNCTION TESTER |
II |
| |
870.4075 |
ENDOMYOCARDIAL BIOPSY DEVICE |
II |
| |
870.4205 |
CARDIOPULMONARY BYPASS BUBBLE DETECTOR |
II |
| |
870.4210 |
CARDIOPULMONARY BYPASS VASCULAR CATHETER, CANNULA, AND TUBING |
II |
| |
870.4270 |
CARDIOPULMONARY BYPASS CARDIOTOMY SUCTION LINE BLOOD FILTER |
II |
| |
870.4280 |
CARDIOPULMONARY PREBYPASS FILTER |
II |
| |
870.4290 |
CARDIOPULMONARY BYPASS ADAPTOR, STOPCOCK, MANIFOLD, OR FITTING |
II |
| |
870.4310 |
CARDIOPULMONARY BYPASS CORONARY PRESSURE GAUGE |
II |
| |
870.4330 |
CARDIOPULMONARY BYPASS ON-LINE BLOOD GAS MONITOR |
II |
| |
870.4340 |
CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR AND/OR CONTROL |
II |
| |
870.4390 |
CARDIOPULMONARY BYPASS PUMP TUBING |
II |
| |
870.4400 |
CARDIOPULMONARY BYPASS BLOOD RESERVOIR |
II |
| |
870.4410 |
CARDIOPULMONARY BYPASS IN-LINE BLOOD GAS SENSOR |
II |
| |
870.4420 |
CARDIOPULMONARY BYPASS CARDIOTOMY RETURN SUCKER |
II |
| |
870.4430 |
CARDIOPULMONARY BYPASS INTRACARDIAC SUCTION CONTROL |
II |
| |
870.4450 |
VASCULAR CLAMP |
II |
| |
870.4475 |
SURGICAL VESSEL DILATOR |
II |
| |
870.4875 |
INTRALUMINAL ARTERY STRIPPER |
II |
| |
870.4885 |
EXTERNAL VEIN STRIPPER |
II |
| |
870.5050 |
PATIENT CARE SUCTION APPARATUS |
II |
| |
870.5150 |
EMBOLECTOMY CATHETER |
II |
| |
870.5175 |
SEPTOSTOMY CATHETER |
II |
| |
870.5325 |
DEFIBRILLATOR TESTER |
II |
| |
870.5800 |
COMPRESSIBLE LIMB SLEEVE |
II |
| |
870.5900 |
THERMAL REGULATION SYSTEM |
II |
| |
870.5925 |
AUTOMATIC ROTATING TOURNIQUET |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Dental |
| |
872.1720 |
PULP TESTER |
II |
| |
872.1740 |
CARIES DETECTION DEVICE |
II |
| |
872.1800 |
EXTRAORAL SOURCE X-RAY SYSTEM |
II |
| |
872.1810 |
INTRAORAL SOURCE X-RAY SYSTEM |
II |
| |
872.1830 |
CEPHALOMETER |
II |
| |
872.3050 |
AMALGAM ALLOY |
II |
| |
872.3060 |
GOLD BASED ALLOYS AND PRECIOUS METAL ALLOYS FOR CLINICAL USE |
II |
| |
872.3200 |
RESIN TOOTH BONDING AGENT |
II |
| |
872.3250 |
CALCIUM HYDROXIDE CAVITY LINER |
II |
| |
872.3260 |
CAVITY VARNISH |
II |
| |
872.3275 |
DENTAL CEMENT |
II |
| |
872.3300 |
HYDROPHILIC RESIN COATING FOR DENTURES |
II |
| |
872.3310 |
COATING MATERIAL FOR RESIN FILLINGS |
II |
| |
872.3540 |
OTC DENTURE PAD AND DENTURE CUSHION |
II |
| |
872.3560 |
OTC DENTURE RELINER |
II |
| |
872.3570 |
OTC DENTURE REPAIR KIT |
II |
| |
872.3590 |
PREFORMED PLASTIC DENTURE TOOTH |
II |
| |
872.3600 |
PARTIALLY FABRICATED DENTURE KIT |
II |
| |
872.3660 |
IMPRESSION MATERIAL |
II |
| |
872.3690 |
TOOTH SHADE RESIN MATERIAL |
II |
| |
872.3700 |
DENTAL MERCURY (U.S.P) |
I |
| |
872.3710 |
BASE METAL ALLOY |
II |
| |
872.3750 |
BRACKET ADHESIVE RESIN AND TOOTH CONDITIONER |
II |
| |
872.3760 |
DENTURE RELINING REPAIRING OR REBASING RESIN |
II |
| |
872.3765 |
PIT AND FISSURE SEALANT AND CONDITIONER |
II |
| |
872.3770 |
TEMPORARY CROWN AND BRIDGE RESIN |
II |
| |
872.3820 |
ROOT CANAL FILLING RESIN |
II |
| |
872.3890 |
ENDODONTIC STABILIZER SPLINT |
II |
| |
872.3920 |
PORCELAIN TOOTH |
II |
| |
872.4120 |
BONE CUTTING INSTRUMENTS AND ACCESSORIES |
II |
| |
872.4200 |
DENTAL HANDPIECES AND ACCESSORIES |
I |
| |
872.4465 |
GAS POWERED JET INJECTOR |
II |
| |
872.4475 |
SPRING-POWERED JET INJECTOR |
II |
| |
872.4840 |
ROTARY SCALER |
II |
| |
872.4850 |
ULTRASONIC SCALER |
II |
| |
872.4920 |
ELECTROSURGICAL UNIT AND ACCESSORIES |
II |
| |
872.5470 |
ORTHODONTIC PLASTIC BRACKET |
II |
| |
872.5550 |
FLUID FILLED TEETHING RING |
II |
| |
872.6070 |
ULTRAVIOLET ACTIVATOR FOR POLYMERIZATION |
II |
| |
872.6080 |
AIRBRUSH |
II |
| |
872.6250 |
CHAIR WITH A UNIT |
I |
| |
872.6350 |
ULTRAVIOLET DETECTOR |
II |
| |
872.6640 |
DENTAL OPERATIVE UNIT |
I |
| |
872.6660 |
PORCELAIN POWDER FOR CLINICAL USE |
II |
| |
872.6710 |
BOILING WATER STERILIZER |
I |
| |
872.6770 |
CARTRIDGE SYRINGE |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Ear Nose & Throat |
| |
874.1090 |
AUDITORY IMPEDANCE TESTER |
II |
| |
874.1120 |
ELECTRONIC NOISE GENERATOR FOR AUDIOMETRIC TESTING |
II |
| |
874.1325 |
ELECTROGLOTTOGRAPH |
II |
| |
874.1820 |
SURGICAL NERVE STIMULATOR/LOCATOR |
II |
| |
874.3300 |
HEARING AID |
II |
| |
874.3310 |
HEARING AID CALIBRATOR AND ANALYSIS SYSTEM |
II |
| |
874.3320 |
GROUP HEARING AID OR GROUP AUDITORY TRAINER |
II |
| |
874.3330 |
MASTER HEARING AID |
II |
| |
874.3400 |
TINNITUS MASKER |
II |
| |
874.3730 |
LARYNGEAL PROSTHESIS (TAUB DESIGN) |
II |
| |
874.4250 |
EAR, NOSE, AND THROAT ELECTRIC OR PNEUMATIC SURGICAL DRILL |
II |
| |
874.4500 |
ENT MICROSURGICAL CARBON DIOXIDE LASER PRODUCT |
II |
| |
874.4680 |
BRONCHOSCOPE (FLEXIBLE OR RIGID) |
II |
| |
874.4710 |
ESOPHAGOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES |
II |
| |
874.4720 |
MEDIASTINOSCOPE AND ACCESSORIES |
II |
| |
874.4760 |
NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Gastroenterology |
| |
876.1075 |
GASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT |
II |
| |
876.1500 |
ENDOSCOPE AND ACCESSORIES |
II |
| |
876.1725 |
GASTROINTESTINAL MOTILITY MONITORING SYSTEM |
II |
| |
876.4020 |
FIBEROPTIC LIGHT URETERAL CATHETER |
II |
| |
876.4270 |
COLOSTOMY ROD |
II |
| |
876.4300 |
ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES |
II |
| |
876.4400 |
HEMORRHOIDAL LIGATOR |
II |
| |
876.4480 |
ELECTROHYDRAULIC LITHOTRIPTOR |
II |
| |
876.4500 |
MECHANICAL LITHOTRIPTOR |
II |
| |
876.4620 |
URETERAL STENT |
II |
| |
876.4770 |
URETHROTOME |
II |
| |
876.5010 |
BILIARY CATHETER AND ACCESSORIES |
II |
| |
876.5090 |
SUPRAPUBIC UROLOGICAL CATHETER AND ACCESSORIES |
II |
| |
876.5130 |
UROLOGICAL CATHETER AND ACCESSORIES |
II |
| |
876.5160 |
UROLOGICAL CLAMPS FOR MALES |
I |
| |
876.5320 |
NONIMPLANTED ELECTRICAL CONTINENCE DEVICE |
II |
| |
876.5365 |
ESOPHAGEAL DILATOR |
II |
| |
876.5470 |
URETERAL DILATOR |
II |
| |
876.5520 |
URETHRAL DILATOR |
II |
| |
876.5540 |
BLOOD ACCESS DEVICE AND ACCESSORIES |
II |
| |
876.5665 |
WATER PURIFICATION SYSTEM FOR DIALYSIS |
II |
| |
876.5820 |
HEMODIALYSIS SYSTEMS AND ACCESSORIES |
II |
| |
876.5880 |
ISOLATED KIDNEY PERFUSION AND TRANSPORT SYSTEM AND ACCESSORIES |
II |
| |
876.5895 |
OSTOMY IRRIGATOR |
II |
| |
876.5980 |
GASTROINTESTINAL TUBE AND ACCESSORIES |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Hematology |
| |
864.1860 |
IMMUNOHISTOCHEMISTRY REAGENTS AND KITS |
II |
| |
864.5260 |
AUTOMATED CELL-LOCATING DEVICE |
II |
| |
864.5300 |
RED CELL INDICES DEVICE |
II |
| |
864.5425 |
MULTIPURPOSE SYSTEM FOR IN VITRO COAGULATION STUDIES |
II |
| |
864.5600 |
AUTOMATED HEMATOCRIT INSTRUMENT |
II |
| |
864.5620 |
AUTOMATED HEMOGLOBIN SYSTEM |
II |
| |
864.5950 |
BLOOD VOLUME MEASURING DEVICE |
II |
| |
864.6550 |
OCCULT BLOOD TEST |
II |
| |
864.7040 |
ADENOSINE TRIPHOSPHATE RELEASE ASSAY |
I |
| |
864.7100 |
RED BLOOD CELL ENZYME ASSAY |
II |
| |
864.7250 |
ERYTHROPOIETIN ASSAY |
II |
| |
864.7275 |
EUGLOBULIN LYSIS TIME TESTS |
II |
| |
864.7300 |
FIBRIN MONOMER PARACOAGULATION TEST |
II |
| |
864.7320 |
FIBRINOGEN/FIBRIN DEGRADATION PRODUCTS ASSAY |
II |
| |
864.7340 |
FIBRINOGEN DETERMINATION SYSTEM |
II |
| |
864.7360 |
ERYTHROCYTIC GLUCOSE-6-PHOSPHATE DEHYDROGENASE ASSAY |
II |
| |
864.7375 |
GLUTATHIONE REDUCTASE ASSAY |
II |
| |
864.7400 |
HEMOGLOBIN A2 ASSAY |
II |
| |
864.7415 |
ABNORMAL HEMOBLOBIN ASSAY |
II |
| |
864.7425 |
CARBOXYHEMOGLOBIN ASSAY |
II |
| |
864.7440 |
ELECTROPHORETIC HEMOGLOBIN ANALYSIS SYSTEM |
II |
| |
864.7455 |
FETAL HEMOGLOBIN ASSAY |
II |
| |
864.7470 |
GLYCOSYLATED HEMOGLOBIN ASSAY |
II |
| |
864.7490 |
SULFHEMOGLOBIN ASSAY |
II |
| |
864.7500 |
WHOLE BLOOD HEMOBLOBIN ASSAYS |
II |
| |
864.7825 |
SICKLE CELL TEST |
II |
| |
864.8100 |
BOTHROPS ATROX REAGENT |
II |
| |
864.8625 |
HEMATOLOGY QUALITY CONTROL MIXTURE |
II |
| |
864.8950 |
RUSSEL VIPER VENOM REAGENT |
I |
| Panel | Section Number | Regulation Name / Device Name | Class |
| General Hospital |
| |
880.2420 |
ELECTRONIC MONITOR FOR GRAVITY FLOW INFUSION SYSTEMS |
II |
| |
880.2460 |
ELECTRICALLY POWERED SPINAL FLUID PRESSURE MONITOR |
II |
| |
880.2500 |
SPINAL FLUID MANOMETER |
II |
| |
880.2800 |
STERILIZATION PROCESS INDICATOR |
II |
| |
880.2910 |
CLINICAL ELECTRONIC THERMOMETER |
II |
| |
880.5025 |
I.V. CONTAINER |
II |
| |
880.5045 |
MEDICAL RECIRCULATING AIR CLEANER |
II |
| |
880.5090 |
LIQUID BANDAGE |
I |
| |
880.5130 |
INFANT RADIANT WARMER |
II |
| |
880.5200 |
INTRAVASCULAR CATHETER |
II |
| |
880.5400 |
NEONATAL INCUBATOR |
II |
| |
880.5410 |
NEONATAL TRANSPORT INCUBATOR |
II |
| |
880.5430 |
NONELECTRICALLY POWERED FLUID INJECTOR |
II |
| |
880.5440 |
INTRAVASCULAR ADMINISTRATION SET |
II |
| |
880.5450 |
PATIENT CARE REVERSE ISOLATION CHAMBER |
II |
| |
880.5570 |
HYPODERMIC SINGLE LUMEN NEEDLE |
II |
| |
880.5580 |
NEEDLE, ACUPUNCTURE, SINGLE USE |
II |
| |
880.5680 |
PEDIATRIC POSITION HOLDER |
I |
| |
880.5700 |
NEONATAL PHOTOTHERAPY UNIT |
II |
| |
880.5725 |
INFUSION PUMP |
II |
| |
880.5780 |
MEDICAL SUPPORT STOCKING |
II |
| |
880.5860 |
PISTON SYRINGE |
II |
| |
880.6100 |
ETHYLENE OXIDE GAS AERATOR CABINET |
II |
| |
880.6250 |
PATIENT EXAMINATION GLOVE |
I |
| |
880.6375 |
PATIENT LUBRICANT |
I |
| |
880.6500 |
MEDICAL ULTRAVIOLET AIR PURIFIER |
II |
| |
880.6710 |
MEDICAL ULTRAVIOLET WATER PURIFIER |
II |
| |
880.6760 |
PROTECTIVE RESTRAINT |
I |
| |
880.6850 |
STERILIZATION WRAP |
II |
| |
880.6860 |
ETHYLENE OXIDE GAS STERILIZER |
II |
| |
880.6870 |
DRY-HEAT STERILIZER |
II |
| |
880.6880 |
STEAM STERILIZER |
II |
| |
880.6885 |
LIQUID CHEMICAL STERILANTS/HIGH LEVEL DISINFECTANTS |
II |
| |
880.6920 |
SYRINGE NEEDLE INTRODUCER |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Immunology |
| |
866.5080 |
ALPHA-1-ANTICHYMOTRYPSIN IMMUNOLOGICAL TEST SYSTEM |
II |
| |
866.5090 |
ANTIMITOCHONDRIAL ANTIBODY IMMUNOLOGICAL TEST SYSTEM |
II |
| |
866.5100 |
ANTINUCLEAR ANTIBODY IMMUNOLOGICAL TEST SYSTEM |
II |
| |
866.5120 |
ANTISMOOTH MUSCLE ANTIBODY IMMUNOLOGICAL TEST SYSTEM |
II |
| |
866.5130 |
ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL TEST SYSTEM |
II |
| |
866.5150 |
BENCE-JONES PROTEINS IMMUNOLOGICAL TEST SYSTEM |
II |
| |
866.5240 |
COMPLEMENT COMPONENTS IMMUNOLOGICAL TEST SYSTEM |
II |
| |
866.5250 |
COMPLEMENT C1 INHIBITOR (INACTIVATOR) IMMUNOLOGICAL TEST SYSTEM |
II |
| |
866.5260 |
COMPLEMENT C3B INACTIVATOR IMMUNOLOGICAL TEST SYSTEM |
II |
| |
866.5270 |
C-REACTIVE PROTEIN IMMUNOLOGICAL TEST SYSTEM |
II |
| |
866.5340 |
FERRITIN IMMUNOLOGICAL TEST SYSTEM |
II |
| |
866.5350 |
FIBRINOPEPTIDE A IMMUNOLOGICAL TEST SYSTEM |
II |
| |
866.5510 |
IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST SYSTEM |
II |
| |
866.5550 |
IMMUNOGLOBULIN (LIGHT CHAIN SPECIFIC) IMMUNOLOGICAL TEST SYSTEM |
II |
| |
866.5580 |
ALPHA-1-LIPOPROTEIN IMMUNOLOGICAL TEST SYSTEM |
II |
| |
866.5600 |
LOW-DENSITY LIPOPROTEIN IMMUNOLOGICAL TEST SYSTEM |
II |
| |
866.5620 |
ALPHA-2-MACROGLOBULIN IMMUNOLOGICAL TEST SYSTEM |
II |
| |
866.5630 |
BETA-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM |
II |
| |
866.5640 |
INFECTIOUS MONONUCLEOSIS IMMUNOLOGICAL TEST SYSTEM |
II |
| |
866.5680 |
MYOGLOBIN IMMUNOLOGICAL TEST SYSTEM |
II |
| |
866.5775 |
RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM |
II |
| |
866.5820 |
SYSTEMIC LUPUS ERYTHEMATOSUS IMMUNOLOGICAL TEST SYSTEM |
II |
| |
866.5870 |
THYROID AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM |
II |
| |
866.5880 |
TRANSFERRIN IMMUNOLOGICAL TEST SYSTEM |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Microbiology |
| |
866.1620 |
ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
II |
| |
866.1640 |
ANTIMICROBIAL SUSCEPTIBILITY TEST POWDER |
II |
| |
866.1700 |
CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEPTIBILITY TESTS |
II |
| |
866.2390 |
TRANSPORT CULTURE MEDIUM |
I |
| |
866.2560 |
MICROBIAL GROWTH MONITOR |
I |
| |
866.2850 |
AUTOMATED ZONE READER |
I |
| |
866.2900 |
MICROBIOLOGICAL SPECIMEN COLLECTION AND TRANSPORT DEVICE |
I |
| |
866.3110 |
CAMPYLOBACTER FETUS SEROLOGICAL REAGENTS |
I |
| |
866.3120 |
CHLAMYDIA SEROLOGICAL REAGENTS |
I |
| |
866.3175 |
CYTOMEGALOVIRUS SEROLOGICAL REAGENTS |
II |
| |
866.3235 |
EPSTEIN-BARR VIRUS SEROLOGICAL REAGENTS |
I |
| |
866.3370 |
MYCOBACTERIUM TUBERCULOSIS IMMUNOFLUORESCENT REAGENTS |
I |
| |
866.3390 |
NEISSERA SPP. DIRECT SEROLOGICAL TEST REAGENTS |
II |
| |
866.3510 |
RUBELLA VIRUS SEROLOGICAL REAGENTS |
II |
| |
866.3780 |
TOXOPLASMA GONDII SEROLOGICAL REAGENTS |
II |
| |
866.3820 |
TREPONEMA PALLIDUM NONTREPONEMAL TEST REAGENTS |
II |
| |
866.3830 |
TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS |
II |
| |
866.3870 |
TRYPANOSOMA SPP. SEROLOGICAL REAGENTS |
I |
| |
866.3900 |
VARICELLA-ZOSTER VIRUS SEROLOGICAL REAGENTS |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Neurology |
| |
882.1020 |
RIGIDITY ANALYZER |
II |
| |
882.1030 |
ATAXIAGRAPH |
I |
| |
882.1240 |
ECHOENCEPHALOGRAPH |
II |
| |
882.1275 |
ELECTROCONDUCTIVE MEDIA |
II |
| |
882.1310 |
CORTICAL ELECTRODE |
II |
| |
882.1320 |
CUTANEOUS ELECTRODE |
II |
| |
882.1330 |
DEPTH ELECTRODES |
II |
| |
882.1340 |
NASOPHARYNGEAL ELECTRODE |
II |
| |
882.1350 |
NEEDLE ELECTRODE |
II |
| |
882.1400 |
ELECTROENCEPHALOGRAPH |
II |
| |
882.1420 |
ELECTROENCEPHALOGRAM (EEG) SIGNAL SPECTRUM ANALYZER |
I |
| |
882.1460 |
NYSTAGMOGRAPH |
II |
| |
882.1480 |
NEUROLOGICAL ENDOSCOPE |
II |
| |
882.1540 |
GALVANIC SKIN RESPONSE MEASUREMENT DEVICE |
II |
| |
882.1550 |
NERVE CONDUCTION VELOCITY MEASUREMENT DEVICE |
II |
| |
882.1560 |
SKIN POTENTIAL MEASUREMENT DEVICE |
II |
| |
882.1570 |
POWERED DIRECT CONTACT TEMPERATURE MEASUREMENT DEVICE |
II |
| |
882.1610 |
ALPHA MONITOR |
II |
| |
882.1620 |
INTRACRANIAL PRESSURE MONITORING DEVICE |
II |
| |
882.1835 |
PHYSIOLOGICAL SIGNAL AMPLIFIER |
II |
| |
882.1845 |
PHYSIOLOGICAL SIGNAL CONDITIONER |
II |
| |
882.1855 |
ELECTROENCEPLELOGRAM (EEG) TELEMETRY SYSTEM |
II |
| |
882.1870 |
EVOKED RESPONSE ELECTRICAL STIMULATOR |
II |
| |
882.1880 |
EVOKED RESPONSE MECHANICAL STIMULATOR |
II |
| |
882.1890 |
EVOKED RESPONSE PHOTIC STIMULATOR |
II |
| |
882.1900 |
EVOKED RESPONSE AUDITORY STIMULATOR |
II |
| |
882.1950 |
TREMOR TRANSDUCER |
II |
| |
882.4060 |
VENTRICULAR CANNULA |
I |
| |
882.4100 |
VENTRICULAR CATHETER |
II |
| |
882.4150 |
SCALP CLIP |
II |
| |
882.4175 |
ANEURYSM CLIP APPLIER |
II |
| |
882.4250 |
CRYOGENIC SURGICAL DEVICE |
II |
| |
882.4275 |
DOWEL CUTTING INSTRUMENT |
II |
| |
882.4300 |
MANUAL CRANIAL DRILLS, BURRS, TREPHINES & ACCESSORIES |
II |
| |
882.4305 |
POWERED COMPOUND CRANIAL DRILLS, BURRS, TREPHINES & ACCESSORIES |
II |
| |
882.4310 |
POWERED SIMPLE CRANIAL DRILLS, BURRS, TREPHINES & ACCESSORIES |
II |
| |
882.4360 |
ELECTRIC CRANIAL DRILL MOTOR |
II |
| |
882.4370 |
PNEUMATIC CRANIAL DRILL MOTOR |
II |
| |
882.4400 |
RADIOFREQUENCY LESION GENERATOR |
II |
| |
882.4460 |
NEUROSURGICAL HEAD HOLDER (SKULL CLAMP) |
II |
| |
882.4545 |
SHUNT SYSTEM IMPLANTATION INSTRUMENT |
I |
| |
882.4560 |
STEREOTAXIC INSTRUMENT |
II |
| |
882.4700 |
COTTONOID PADDIE |
II |
| |
882.4725 |
RADIOFREQUENCY LESION PROBE |
II |
| |
882.4800 |
SELF-RETAINING RETRACTOR FOR NEUROSURGERY |
II |
| |
882.4840 |
MANUAL RONGEUR |
II |
| |
882.4845 |
POWERED RONGEUR |
II |
| |
882.5070 |
BITE BLOCK |
II |
| |
882.5235 |
AVERSIVE CONDITIONING DEVICE |
II |
| |
882.5500 |
LESION TEMPERATURE MONITOR |
II |
| |
882.5810 |
EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR |
II |
| |
882.5890 |
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR FOR PAIN RELIEF |
II |
| |
882.5960 |
SKULL TONG FOR TRACTION |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Obstetrics/Gynecology |
| |
884.1050 |
ENDOCERVICAL ASPIRATOR |
II |
| |
884.1060 |
ENDOMETRIAL ASPIRATOR |
II |
| |
884.1100 |
ENDOMETRIAL BRUSH |
II |
| |
884.1175 |
ENDOMETRIAL SUCTION CURETTE AND ACCESSORIES |
II |
| |
884.1185 |
ENDOMETRIAL WASHER |
II |
| |
884.1300 |
UTEROTUBAL CARBON DIOXIDE INSUFFLATOR AND ACCESSORIES |
II |
| |
884.1560 |
FETAL BLOOD SAMPLER |
II |
| |
884.1630 |
COLPOSCOPE (AND COLPOMICROSCOPE) |
II |
| |
884.1660 |
TRANSCERVICAL ENDOSCOPE (AMNIOSCOPE) AND ACCESSORIES |
II |
| |
884.1690 |
HYSTEROSCOPE AND ACCESSORIES |
II |
| |
884.1700 |
HYSTEROSCOPIC INSUFFLATOR |
II |
| |
884.1720 |
GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES |
II |
| |
884.1730 |
LAPAROSCOPIC INSUFFLATOR |
II |
| |
884.2225 |
OBSTETRIC-GYNECOLOGIC ULTRASONIC IMAGER |
II |
| |
884.2600 |
FETAL CARDIAC MONITOR |
II |
| |
884.2640 |
FETAL PHONOCARDIOGRAPHIC MONITOR AND ACCESSORIES |
II |
| |
884.2660 |
FETAL ULTRASONIC MONITOR AND ACCESSORIES |
II |
| |
884.2675 |
FETAL SCALP CIRCULAR (SPIRAL) ELECTRODE AND APPLICATOR |
II |
| |
884.2700 |
INTRAUTERINE PRESSURE MONITOR AND ACCESSORIES |
II |
| |
884.2720 |
EXTERNAL UTERINE CONTRACTION MONITOR AND ACCESSORIES |
II |
| |
884.2740 |
PERINATAL MONITORING SYSTEM AND ACCESSORIES |
II |
| |
884.2960 |
OBSTETRIC ULTRASONIC TRANSDUCER AND ACCESSORIES |
II |
| |
884.2980 |
TELETHERMOGRAPHIC SYSTEM |
I |
| |
884.2982 |
LIQUID CRYSTAL THERMOGRAPHIC SYSTEM |
I |
| |
884.3200 |
CERVICAL DRAIN |
II |
| |
884.3575 |
VAGINAL PESSARY |
II |
| |
884.3900 |
VAGINAL STENT |
II |
| |
884.4120 |
GYNECOLOGIC ELECTROCAUTERY AND ACCESSORIES |
II |
| |
884.4160 |
UNIPOLAR ENDOSCOPIC COAGULATOR-CUTTER AND ACCESSORIES |
II |
| |
884.4260 |
HYGROSCOPIC-LAMINARIA CERVICAL DILATOR |
II |
| |
884.4340 |
FETAL VACUUM EXTRACTOR |
II |
| |
884.4400 |
OBSTETRIC FORCEPS |
II |
| |
884.4500 |
OBSTETRIC FETAL DESTRUCTIVE INSTRUMENT |
II |
| |
884.4530 |
OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT |
II |
| |
884.4550 |
GYNECOLOGIC SURGICAL LASER |
II |
| |
884.4900 |
OBSTETRIC TABLE AND ACCESSORIES |
II |
| |
884.5070 |
VACUUM ABORTION SYSTEM |
II |
| |
884.5100 |
OBSTETRIC ANESTHESIA SET |
II |
| |
884.5160 |
POWERED BREAST PUMP |
II |
| |
884.5250 |
CERVICAL CAP |
II |
| |
884.5300 |
CONDOM |
II |
| |
884.5310 |
CONDOM WITH SPERMICIDAL LUBRICANT |
II |
| |
884.5350 |
CONTRACEPTIVE DIAPHRAGM (AND ACCESSORIES) |
II |
| |
884.5390 |
PERINEAL HEATER |
II |
| |
884.5400 |
MENSTRUAL CUP |
II |
| |
884.5425 |
SCENTED OR SCENTED DEODORIZED MENSTRUAL PAD |
II |
| |
884.5460 |
SCENTED OR SCENTED DEODORIZED MENSTRUAL TAMPON |
II |
| |
884.5470 |
UNSCENTED MENSTRUAL TAMPON |
II |
| |
884.5960 |
GENITAL VIBRATOR FOR THERAPEUTIC USE |
II |
| |
884.6100 |
ASSISTED REPRODUCTION NEEDLE |
II |
| |
884.6110 |
ASSISTED REPRODUCTION CATHETER |
II |
| |
884.6120 |
ASSISTED REPRODUCTION ACCESSORY |
II |
| |
884.6130 |
ASSISTED REPRODUCTION MICROTOOLS |
II |
| |
884.6140 |
ASSISTED REPRODUCTION MICROTOOL FABRICATION INSTRUMENTATION |
II |
| |
884.6150 |
ASSISTED REPRODUCTION MICROMANIPULATORS AND MICROINJECTORS |
II |
| |
884.6160 |
ASSISTED REPRODUCTION LABWARE |
II |
| |
884.6180 |
REPRODUCTIVE MEDIA AND SUPPLEMENTS |
II |
| |
884.6190 |
ASSISTED REPRODUCTION MICROSCOPE AND MICROSCOPE ACCESSORIES |
I |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Ophthalmic |
| |
886.1120 |
AC-POWERED OPHTHALMIC CAMERA |
II |
| |
886.1220 |
CORNEAL ELECTRODE |
II |
| |
886.1250 |
EUTHYSCOPE |
II |
| |
886.1300 |
AFTER IMAGE FLASHER |
II |
| |
886.1360 |
VISUAL FIELD LASER INSTRUMENT |
II |
| |
886.1385 |
POLYMETHYLMETHACRYLATE DIAGNOSTIC CONTACT LENS |
II |
| |
886.1510 |
EYE MOVEMENT MONITOR |
II |
| |
886.1570 |
OPHTHALMOSCOPE - 2 CLASSES |
II |
| |
886.1630 |
AC-POWERED PHOTOSTIMULATOR |
II |
| |
886.1640 |
OPHTHALMIC PREAMPLIFIER |
II |
| |
886.1670 |
OPHTHALMIC ISOTOPE UPTAKE PROBE |
II |
| |
886.1780 |
RETINOSCOPE |
II |
| |
886.1850 |
AC-POWERED SLIT-LAMP BIOMICROSCOPE |
II |
| |
886.1930 |
TONOMETER AND ACCESSORIES |
II |
| |
886.1945 |
TRANSILLUMINATOR |
II |
| |
886.3400 |
KERATOPROSTHESIS |
II |
| |
886.4070 |
POWERED CORNEAL BURR |
I |
| |
886.4100 |
RADIOFREQUENCY CAUTERY APPARATUS |
II |
| |
886.4115 |
THERMAL CAUTERY UNIT |
II |
| |
886.4150 |
VITREOUS ASPIRATION AND CUTTING INSTRUMENT |
II |
| |
886.4170 |
CRYOPHTHALMIC UNIT |
II |
| |
886.4250 |
OPHTHALMIC ELECTROLYSIS UNIT |
II |
| |
886.4300 |
INTRAOCULAR LENS GUIDE |
I |
| |
886.4335 |
OPERATING HEADLAMP |
II |
| |
886.4370 |
KERATOME |
I |
| |
886.4390 |
OPHTHALMIC LASER |
II |
| |
886.4392 |
ND:YAG LASER FOR POSTERIOR CAPSULOTOMY |
II |
| |
886.4400 |
ELECTRONIC METAL LOCATOR |
II |
| |
886.4440 |
AC-POWERED MAGNET |
II |
| |
886.4610 |
OCULAR PRESSURE APPLICATOR |
II |
| |
886.4670 |
PHACOFRAGMENTATION SYSTEM |
II |
| |
886.4690 |
OPHTHALMIC PHOTOCOAGULATOR |
II |
| |
886.4790 |
OPHTHALMIC SPONGE |
II |
| |
886.5100 |
OPHTHALMIC BETA RADIATION SOURCE |
II |
| |
886.5916 |
RIGID GAS PERMEABLE CONTACT LENS |
II |
| |
886.5918 |
RIGID GAS PERMEABLE CONTACT LENS CARE PRODUCTS |
II |
| |
886.5925 |
SOFT (HYDROPHILIC) CONTACT LENS |
II |
| |
886.5928 |
SOFT (HYDROPHYLIC) CONTACT LENS CARE PRODUCTS |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Orthopedic |
| |
888.1100 |
ARTHROSCOPE |
II |
| |
888.1240 |
AC-POWERED DYNAMOMETER |
II |
| |
888.1500 |
AC-POWERED GONIOMETER |
I |
| |
888.4580 |
SONIC SURGICAL INSTRUMENT AND ACCESSORIES/ATTACHMENTS |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Physical Medicine |
| |
890.1225 |
CHRONAXIMETER |
II |
| |
890.1375 |
DIAGNOSTIC ELECTROMYOGRAPH |
II |
| |
890.1385 |
DIAGNOSTIC ELECTROMYOGRAPH NEEDLE ELECTRODE |
II |
| |
890.1450 |
POWERED REFLEX HAMMER |
II |
| |
890.1850 |
DIAGNOSTIC MUSCLE STIMULATOR |
II |
| |
890.3110 |
ELECTRIC POSITIONING CHAIR |
II |
| |
890.3690 |
POWERED WHEELED STRETCHER |
II |
| |
890.3800 |
MOTORIZED THREE-WHEELED VEHICLE |
II |
| |
890.3850 |
MECHANICAL WHEELCHAIR |
I |
| |
890.3860 |
POWERED WHEELCHAIR |
II |
| |
890.3880 |
SPECIAL GRADE WHEELCHAIR |
II |
| |
890.3900 |
STANDUP WHEELCHAIR |
II |
| |
890.3930 |
WHEELCHAIR ELEVATOR |
II |
| |
890.5100 |
IMMERSION HYDROBATH |
II |
| |
890.5110 |
PARAFFIN BATH |
II |
| |
890.5150 |
POWERED PATIENT TRANSPORT |
II |
| |
890.5250 |
MOIST STEAM CABINET |
II |
| |
890.5275 |
MICROWAVE DIATHERMY |
II |
| |
890.5290 |
SHORTWAVE DIATHERMY |
II |
| |
890.5300 |
ULTRASONIC DIATHERMY |
II |
| |
890.5360 |
MEASURING EXERCISE EQUIPMENT |
II |
| |
890.5500 |
INFRARED LAMP |
II |
| |
890.5525 |
IONTOPHORESIS DEVICE |
II |
| |
890.5575 |
POWERED EXTERNAL LIMB OVERLOAD WARNING DEVICE |
II |
| |
890.5650 |
POWERED INFLATABLE TUBE MASSAGER |
II |
| |
890.5710 |
HOT OR COLD DISPOSABLE PACK |
I |
| |
890.5850 |
POWERED MUSCLE STIMULATOR |
II |
| |
890.5860 |
ULTRASOUND AND MUSCLE STIMULATOR |
II |
| |
890.5880 |
MULTI-FUNCTION PHYSICAL THERAPY TABLE |
II |
| |
890.5900 |
POWERED TRACTION EQUIPMENT |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Radiology |
| |
892.1000 |
MAGNETIC RESONANCE DIAGNOSTIC DEVICE |
II |
| |
892.1100 |
SCINTILLATION GAMMA CAMERA |
I |
| |
892.1110 |
POSITRON CAMERA |
I |
| |
892.1200 |
EMISSION COMPUTED TOMOGRAPHY SYSTEM |
II |
| |
892.1220 |
FLUORESCENT SCANNER |
II |
| |
892.1310 |
NUCLEAR TOMOGRAPHIC SYSTEM |
II |
| |
892.1360 |
RADIONUCLIDE DOSE CALIBRATOR |
II |
| |
892.1390 |
RADIONUCLIDE REBREATHING SYSTEM |
II |
| |
892.1540 |
NONFETAL ULTRASONIC MONITOR |
II |
| |
892.1550 |
ULTRASONIC PULSED DOPPLER IMAGING SYSTEM |
II |
| |
892.1560 |
ULTRASONIC PULSED ECHO IMAGING SYSTEM |
II |
| |
892.1570 |
DIAGNOSTIC ULTRASONIC TRANSDUCER |
II |
| |
892.1600 |
ANGIOGRAPHIC X-RAY SYSTEM |
II |
| |
892.1610 |
DIAGNOSTIC X-RAY BEAM LIMITING DEVICE |
II |
| |
892.1620 |
CINE OR SPOT FLUOROGRAPHIC X-RAY CAMERA |
II |
| |
892.1630 |
ELECTROSTATIC X-RAY IMAGING SYSTEM |
II |
| |
892.1650 |
IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM |
II |
| |
892.1660 |
NON-IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM |
II |
| |
892.1670 |
SPOT FILM DEVICE |
II |
| |
892.1680 |
STATIONARY X-RAY SYSTEM |
II |
| |
892.1710 |
MAMMOGRAPHIC X-RAY SYSTEM |
II |
| |
892.1720 |
MOBILE X-RAY SYSTEM |
II |
| |
892.1730 |
PHOTOFLUOROGRAPHIC X-RAY SYSTEM |
II |
| |
892.1740 |
TOMOGRAPHIC X-RAY SYSTEM |
II |
| |
892.1750 |
COMPUTED TOMOGRAPHY X-RAY SYSTEM |
II |
| |
892.1820 |
PNEUMOENCEPHALOGRAPHIC CHAIR |
II |
| |
892.1850 |
RADIOGRAPHIC FILM CASSETTE |
II |
| |
892.1860 |
RADIOGRAPHIC FILM/CASSETTE CHANGER |
II |
| |
892.1870 |
RADIOGRAPHIC FILM/CASSETTE CHANGER PROGRAMMER |
II |
| |
892.1900 |
AUTOMATIC RADIOGRAPHIC-FILM PROCESSOR |
II |
| |
892.2030 |
MEDICAL IMAGE DIGITIZER |
II |
| |
892.2040 |
MEDICAL IMAGE HARDCOPY DEVICE |
II |
| |
892.2050 |
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS |
II |
| |
892.5050 |
MEDICAL CHARGED-PARTICLE RADIATION THERAPY SYSTEM |
II |
| |
892.5300 |
MEDICAL NEUTRON RADIATION THERAPY SYSTEM |
II |
| |
892.5700 |
REMOTE CONTROLLED RADIONUCLIDE-APPLICATOR SYSTEM |
II |
| |
892.5710 |
RADIATION THERAPY BEAM-SHAPING BLOCK |
II |
| |
892.5730 |
RADIONUCLIDE BRACHYTHERAPY SOURCE |
II |
| |
892.5750 |
RADIONUCLIDE RADIATION THERAPY SYSTEM |
II |
| |
892.5770 |
POWERED RADIATION THERAPY PATIENT SUPPORT ASSEMBLY |
II |
| |
892.5840 |
RADIATION THERAPY SIMULATION SYSTEM |
II |
| |
892.5900 |
X-RAY RADIATION THERAPY SYSTEM |
II |
| |
892.5930 |
THERAPEUTIC X-RAY TUBE HOUSING ASSEMBLY |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| General & Plastic Surgery |
| |
878.4040 |
SURGICAL APPAREL |
II |
| |
878.4350 |
CRYOSURGICAL UNIT AND ACCESSORIES |
II |
| |
878.4370 |
SURGICAL DRAPE AND DRAPE ACCESSORIES |
II |
| |
878.4400 |
ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES |
II |
| |
878.4460 |
SURGEON`S GLOVES |
I |
| |
878.4580 |
SURGICAL LAMP |
II |
| |
878.4630 |
DERMATOLOGIC ULTRAVIOLET LAMP |
II |
| |
878.4780 |
POWERED SUCTION PUMP |
II |
| |
878.4810 |
LASER SURGICAL INSTRUMENT FOR USE IN GENERAL & PLASTIC SURGERY & IN DERMATOLOGY |
II |
| |
878.5040 |
SUCTION LIPOPLASTY SYSTEM |
II |
| |
878.5070 |
AIR-HANDLING APPARATUS FOR A SURGICAL OPERATING ROOM |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Toxicology |
| |
862.3030 |
ACETAMINOPHEN TEST SYSTEM |
II |
| |
862.3035 |
AMIKACIN TEST SYSTEM |
II |
| |
862.3040 |
ALCOHOL TEST SYSTEM |
II |
| |
862.3050 |
BREATH-ALCOHOL TEST SYSTEM |
I |
| |
862.3100 |
AMPHETAMINE TEST SYSTEM |
II |
| |
862.3110 |
ANTIMONY TEST SYSTEM |
I |
| |
862.3120 |
ARSENIC TEST SYSTEM |
I |
| |
862.3150 |
BARBITURATE TEST SYSTEM |
II |
| |
862.3170 |
BENZODIAZEPINE TEST SYSTEM |
II |
| |
862.3200 |
CLINICAL TOXICOLOGY CALIBRATOR |
II |
| |
862.3220 |
CARBON MONOXIDE TEST SYSTEM |
I |
| |
862.3240 |
CHOLINESTERASE TEST SYSTEM |
I |
| |
862.3250 |
COCAINE AND COCAINE METABOLITE TEST SYSTEM |
II |
| |
862.3270 |
CODEINE TEST SYSTEM |
II |
| |
862.3280 |
CLINICAL TOXICOLOGY CONTROL MATERIAL |
I |
| |
862.3300 |
DIGITOXIN TEST SYSTEM |
II |
| |
862.3320 |
DIGOXIN TEST SYSTEM |
II |
| |
862.3350 |
DIPHENYLHYDANTOIN TEST SYSTEM |
II |
| |
862.3380 |
ETHOSUXIMIDE TEST SYSTEM |
II |
| |
862.3450 |
GENTAMICIN TEST SYSTEM |
II |
| |
862.3520 |
KANAMYCIN TEST SYSTEM |
II |
| |
862.3550 |
LEAD TEST SYSTEM |
II |
| |
862.3555 |
LIDOCAINE TEST SYSTEM |
II |
| |
862.3560 |
LITHIUM TEST SYSTEM |
II |
| |
862.3580 |
LYSERGIC ACID DIETHYLAMIDE (LSD) TEST SYSTEM |
II |
| |
862.3600 |
MERCURY TEST SYSTEM |
I |
| |
862.3610 |
METHAMPHETAMINE TEST SYSTEM |
II |
| |
862.3620 |
METHADONE TEST SYSTEM |
II |
| |
862.3630 |
METHAQUALONE TEST SYSTEM |
II |
| |
862.3640 |
MORPHINE TEST SYSTEM |
II |
| |
862.3645 |
NEUROLEPTIC DRUGS RADIORECEPTOR ASSAY TEST SYSTEM |
II |
| |
862.3650 |
OPIATE TEST SYSTEM |
II |
| |
862.3660 |
PHENOBARBITAL TEST SYSTEM |
II |
| |
862.3670 |
PHENOTHIAZINE TEST SYSTEM |
II |
| |
862.3680 |
PRIMIDONE TEST SYSTEM |
II |
| |
862.3700 |
PROPOXYHPENE TEST SYSTEM |
II |
| |
862.3750 |
QUININE TEST SYSTEM |
I |
| |
862.3830 |
SALICYLATE TEST SYSTEM |
II |
| |
862.3850 |
SULPHANIMIDE TEST SYSTEM |
I |
| |
862.3870 |
CANNABINOID TEST SYSTEM |
II |
| |
862.3880 |
THEOPHYLLINE TEST SYSTEM |
II |
| |
862.3900 |
TOBRAMYCIN TEST SYSTEM |
II |
| |
862.3910 |
TRICYCLIC ANTIDEPRESSANT DRUGS TEST SYSTEM |
II |
| |
862.3950 |
VANCOMYCIN TEST SYSTEM |
II |
| | unclassified | PHENCYCLIDINE (PCP) TEST SYSTEM: THIN LAYER CHROMATOGRAPHY | |
| | unclassified | PHENCYCLIDINE (PCP) TEST SYSTEM: RADIOIMMUNOASSAY | |
| | unclassified | PHENCYCLIDINE (PCP) TEST SYSTEM: ENZYME IMMUNOASSAY | |
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